The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents
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|ClinicalTrials.gov Identifier: NCT02499705|
Recruitment Status : Terminated (Prematurely unblinded based on outcome in other trial. 2 out of 3 particpants in one arm had clinically elevated fasting insulin. Adverse event was reported.)
First Posted : July 16, 2015
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance Obesity||Dietary Supplement: Sucralose Dietary Supplement: Sucrose Dietary Supplement: Sucralose + maltodextrin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adolescents|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Flavored beverage with sucralose.
Dietary Supplement: Sucralose
Flavored beverage with sucrose.
Dietary Supplement: Sucrose
equisweet to sucralose
Experimental: Sucralose + maltodextrin
Flavored beverage with Splenda + maltodextrin .
Dietary Supplement: Sucralose + maltodextrin
sucralose plus equicaloric (to sucrose) maltodextrin
- Ratings of taste sensitivity [ Time Frame: on average 2 weeks ]At baseline and after on average 2 weeks, subjects will rate intensity of sucrose, sucralose, mono potassium glutamate, sodium chloride and citric acid using the General Labeled Magnitude Scale (gLMS). It is a vertical line with quasi-logarithmic spaced labels that start at the bottom with 'barely detectable' to 'strongest imaginable' at the top, recoded to 0-100.
- Insulin resistance and GLP-1 [ Time Frame: on average 2 weeks ]We will draw a blood sample to assess glucose, insulin and GLP-1
- Ad libitum food intake [ Time Frame: on average 2 weeks ]Subject is offered milk and cereal and asked to consume as much as they want. The amount consumed is measured in weight and converted to calories.
- percent signal change of brain response in reward and gustatory areas to taste stimuli [ Time Frame: on average 2 weeks ]brain response in reward and gustatory areas to sucrose, mono potassium glutamate, sodium chloride and citric acid (in percent signal change).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499705
|United States, Connecticut|
|The John B. Pierce Laboratory|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Dana M Small, PhD||The John B. Pierce Laboratory/Yale University|